GE-Nellcor

GUDID 06946725523728

APK Technology Co.,Ltd.

Tissue saturation oximeter sensor, reprocessed
Primary Device ID06946725523728
NIH Device Record Keyb3cb90ea-147c-414e-8a51-dc0b3924b5da
Commercial Distribution StatusIn Commercial Distribution
Brand NameGE-Nellcor
Version Model NumberA1418-SA203PV
Company DUNS529691989
Company NameAPK Technology Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106946725523728 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-03-06

On-Brand Devices [GE-Nellcor]

06946725523766A1418-SW203PU
06946725523759A1418-SP203PU
06946725523742A1418-SP203PV
06946725523735A1418-SA203PU
06946725523728A1418-SA203PV

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